US-based drugmaker Mylan announced on 9 July 2019 the launch of its adalimumab biosimilar, Hulio, in Spain; the company’s first biosimilar in the country.
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.
Mylan and partner Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics received European Commission (EC) approval for their adalimumab biosimilar Hulio (FKB327) in September 2018 [1]. The EC approval followed the adoption of a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which concluded that the development programme including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with Humira [2].
General Director of Mylan Spain, Dr Christophe Maupas, said that ‘rheumatoid arthritis affects some 300,000 people in Spain, while it is estimated that there are between 84,000 and 120,000 people affected by Inflammatory Bowel Disease (42% of which suffer from Crohn's disease). In addition, 2.3% of the Spanish population suffers from psoriasis’.
Dr Maupas added that ‘the arrival of Hulio to Spain responds to our firm commitment to the health of the Spanish population and to the sustainability of the National Health System, showing that it can make investments in favour of innovation and patient care and confirming the strategy of the company that is intending to lead the segment of biosimilars, since Hulio is the first of a score of biosimilars that are in development’.
Hulio is part of a portfolio of 20 biosimilars that Mylan currently has in the market or in development. Mylan gained EC approval for its insulin biosimilar Semglee in March 2018 [3] and also received a positive recommendation for its pegfilgrastim biosimilar Fulphila in September 2018 [4].
In addition, Dr Maupas stresses that ‘Hulio has a retractable needle in the syringe, which reduces the risk of accidental puncture after use; the body of the syringe is made of plastic and not glass, which improves its safety in case of falls; or that the dispenser of the pen is by pressure and not through a button, which benefits the lack of mobility in the hand’.
Mylan first launched Hulio in major European markets back in October 2018 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-and-pegfilgrastim-biosimilars-Hulio-and-Udenyca
2. GaBI Online - Generics and Biosimilars Initiative. EMA approves adalimumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-adalimumab-and-pegfilgrastim-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Insulin biosimilar Semglee gains EC and Australian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/Insulin-biosimilar-Semglee-gains-EC-and-Australian-approval
4. GaBI Online - Generics and Biosimilars Initiative. EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-pegfilgrastim-biosimilars-Fulphila-Pelmeg-and-Ziextenzo
5. GaBI Online - Generics and Biosimilars Initiative. Mylan gains nod for Ogivri and launches Hulio in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/Mylan-gains-nod-for-Ogivri-and-launches-Hulio-in-Europe
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